(35 days)
Duralastic I (Short Term) Nasal Splinting, Wound Dressings, wound covering for gastroschisis, suture bolsters, drains, Scar Coverings, Laboratory Uses, Temporary facilitation of osteogenesis and guided tissue regeneration between the teeth and gingival margin, or external ear canal for example, temporary joing andrea and other short term uses according to the surgeon's determination.
Chalastic II (Long Term) Nonreinforced - Tympanic Membrane Repair, Pural Covering . 005inch, Nasal Septal Repair, Tendon Anatomobile, na ral repair - 007inch. Correction of Strabismus .010inch, Galea Repair Shunt Anchors . 060inch. Reinforced - Facilitation of Osteogenesis 007 hon, repair of urethral strictures .007inch, Staged Repair of mphalocoel . 020inch, Repair of Orbital Floor Fractures .040inch.
Duralastic I and II Silicone Elastomer Sheeting is made from a biocompatible silicone high consistency rubber, HCRP-50 made by Applied Silicone. It is available in polyester mesh reinforced and nonreinforced in a variety of thicknesses. The silicone elastomer used to make this product have met all Biocompatibility Guidelines set for by FDA for the replacement of Dow Corning Products. These biomaterial standards exceed or meet Class VI USP Standards in that they include Teratogenicity, Mutagenicity, Carcinogenicity and Toxicity Testing. These referenced material characterizations are found in Applied Master File - MAF 704. Duralastic Sheeting is a peroxide cured rubber of a 45 - 55 Durometer hardness (Shore A). It has an elasticity of 700 percent with a tensile strength of 1600 psi and a tear strength of 190 psi (Tear Die C). The elasticity is greatly reduced in the polyester reinforced sheets. The specific gravity is 1.16. Chemically Duralastic I and II are made from HCRA-50, an Applied Silicone dimethylpolysiloxane.
The provided text is a 510(k) summary for the Duralastic I and Duralastic II Silicone Sheeting. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving that a device meets specific acceptance criteria through a clinical study. Therefore, the information requested in your prompt (acceptance criteria, study details, expert qualifications, sample sizes for test/training sets, MRMC study, standalone performance, ground truth) is not applicable to this document.
The document focuses on:
- Product Description: Material composition, available forms.
- Substantial Equivalence: Comparing Duralastic I and II to predicate devices (Applied Biomaterial Technologies Duralastic Sheeting and Dow Corning's Silastic Sheeting) based on material, size, thickness, and intended use. The core argument for SE is that it's made from Dow Corning analogs.
- Intended Uses: Extensive list of short-term and long-term medical applications.
- Physical and Chemical Properties: Durometer hardness, elasticity, tensile strength, tear strength, specific gravity, chemical composition. These are material specifications, not performance criteria in the sense of a clinical outcome study.
- Sterilization Cycle: Details on gamma radiation sterilization and its validation according to ANSI/AAMI/ISO 11137-1994.
There is no mention of an acceptance criteria table, a clinical study design, expert panel adjudication, or any data related to diagnostic performance as typically requested for AI/diagnostic devices. The approval is based on a determination of substantial equivalence, which primarily relies on comparison to existing legally marketed devices, material characterization (biocompatibility, physical properties), and manufacturing processes rather than clinical performance data from a specific study.
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.